Effectiveness of ROTEM-based Coagulation Surveillance on Reducing Blood Product Utilization During Complex Spine Surgery

NCT02758184 | Terminated Results

• 1 other identifier: Pro00070817
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The Purpose of this study is to identify added value of Rotational thrombo-elastometry (ROTEM) intra-operative coagulation surveillance on reducing blood product use during major reconstructive spine surgery.

Conditions

Spine Surgery; Rotational Thrombo-elastometry (ROTEM)

Outcome Measures

Primary Outcomes (2)

• Estimated Blood Loss (mL)

  during surgery (up to approximately 10 hours)

• Total Number of Units of Packed Red Blood Cells (PRBCs) Transfused

  up to 48 hours after surgery

Secondary Outcomes (12)

• Length of Hospital Stay After Surgery

  typically 5-7 days

• Cost Analysis, as Measured by Total Dollar Value of Blood Products Used

  during surgery (up to approximately 10 hours)

• Amount of Recovered Blood Transfused During the Procedure (mL)

  during surgery (up to approximately 10 hours)

• Drain Output (mL)

  first 24 hours after surgery

• Amount of Blood Products Transfused, Measured in Units

  during surgery (up to approximately 10 hours)

Study Arms (2)

ROTEM Group

EXPERIMENTAL

Patients who are randomized to receive ROTEM

Device: ROTEM-based coagulation monitoring; Procedure: Spine surgery

Control Group

OTHER

Patients who are randomized not to receive ROTEM

Procedure: Spine surgery

Interventions

ROTEM-based coagulation monitoring DEVICE

ROTEM Group

Spine surgery PROCEDURE

Control Group; ROTEM Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 and \< 80 years old.
• Elective spine surgery cases, with a traditional open posterior approach and involving fusion of at least 5 levels.
• Normal coagulation profile (PT/INR, aPTT) and normal platelets count on pre-operative evaluation.
• Preoperative hemoglobin Level \>10 g/dl.
• OR time \> 4 hours.
• No contraindication for the use of anti-fibrinolytic therapy (Tranexamic acid).

You may not qualify if:

• Age \< 18 or age \> 80 years old.
• Anterior spine surgeries or posterior spine surgeries involving \<5 levels.
• Minimally invasive spine surgeries.
• Patients with known coagulopathies or bleeding tendencies or patients with abnormal coagulation laboratory values at baseline.
• Patients with Hemoglobin level of \<10 g/dl on preoperative baseline laboratory values.
• Trauma and Emergency spine surgeries.
• Patients with spine malignancy diagnosis, either primary or metastatic.
• OR time \< 4 hours.
• Patients who refuse to use allogenic blood products.
• Patients with contraindications for the use of anti-fibrinolytic therapy.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Results Point of Contact

• Title: Sergio Mendoza Lattes, M.D.
• Organization: Duke University

sergio.mendoza@duke.edu

919-684-2023

Study Officials

• Sergio Mendoza-Lattes

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: May 2, 2016
• Study Start: June 1, 2016
• Primary Completion: May 16, 2018
• Study Completion: May 16, 2018
• Last Updated: April 27, 2022
• Results First Posted: April 27, 2022

Record last verified: 2022-03

Locations

US (1)